Medical Writer

P

Precision Life Sciences

Medical Writer

Boston, MA
Full Time
Paid
  • Responsibilities

    Job Title: Medical Writer

    PRINCIPLE DUTIES:

    • Write, edit, and finalize NDA, IND, CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents 
    • As needed, write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents 
    • Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients 
    • Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents 
    • Lead document review meetings and discussions 
    • Provide direction and solutions to cross-functional teams on expectations for document content 
    • Perform QC of clinical and nonclinical documents 
    • Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines 
    • Participate in project team meetings 

    QUALIFICATIONS/EXPERIENCE:

    • Minimum of Bachelor’s degree in science (Masters or Ph.D. preferred) 
    • Experience in IND and/or NDA submissions and writing CSRs, IBs, clinical study protocols, and other documents for regulatory submissions 
    • A minimum of 5 years in Medical Writing with experience of marketing application submissions (NDAs and MAAs, associated pivotal CSRs) is preferred. 
    • Strong scientific background in rheumatology, endocrinology, metabolic disease, or related field 


    KEY COMPETENCIES:

    • Excellent verbal and written communication skills in English 
    • Knowledge of FDA, EMA, and ICH guidelines. 
    • Deep understanding of the drug development process and prior experience in the biopharmaceutical industry particularly in preparing the NDA. 
    • Excellent time- and project management skills, attention to detail, and ability to balance multiple projects simultaneously 
    • Strong critical and logical thinking with the ability to analyze problems, identify alternative solutions, and implement recommendations for resolution 
    • Ability to work collaboratively in a dynamic environment 
    • Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates